Investigation of the Effects of Noninvasive Neuromodulation in Patients With Acute Ischemic Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- NIHSS (National Institutes of Health Stroke Scale)
研究概览
简要总结
Non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe in participants with cerebral infarction. However, few studies have been done in participants with acute cerebral infarction. In this study, the investigators want to see the effect of tDCS in acute cerebral infarction. the investigators perform tDCS in participants with acute ischemic stroke within 48 hours after stroke onset and the investigators measure motor weakness and function at early phase as well as at 3 months.
详细描述
Cerebral infarction is a major cause of death, a disease that is socially and nationally burdensome, leaving disabilities and dementia behind.
In participants with cerebral infarction, non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe. However, few studies have been done in participants with acute cerebral infarction, and previous studies in participants with acute cerebral infarction have not verified the effect in mild cerebral infarction, and previous studies in acute cerebral infarction mainly stimulate lesions to anode. So in this study, the investigators want to see the effect of stimulating tDCS to both hemispheres in acute cerebral infarction against this backdrop.
Study Objective: To see if tDCS is effective in improving motor paralysis in participants with acute cerebral infarction.
Expected effectiveness: stability of tDCS has already been demonstrated in many studies. Since tDCS itself is a non-invasive treatment, if the efficacy of the tDCS prove to be effective in patients with acute cerebral infarction, it can be widely implemented without significant risk to many patients.
Intervention : In this randomized controlled trial, the investigators perform tDCS in patients with acute ischemic stroke within 48 hours after stroke onset with sham control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded randomized control trial
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic stroke patients within 2 days stroke onset
- •18-85 of age
- •corticospinal tract involvement stroke (primary motor cortex, corona radiata, internal capsule, midbrain crus cerebri, basis pontis, anterior medulla)
排除标准
- •pre-stroke disability (defined as modified Rankin Scale (mRS) >=2)
- •Intravenous r-tPA thrombolysis or EVT (endovascular thrombectomy)
- •history of epilepsy
- •advanced systemic disease or coexisting neurological/psychiatric disease
- •severe contact dermatitis or skin lesions interfering with the applying the electrode of tDCS
结局指标
主要结局
NIHSS (National Institutes of Health Stroke Scale)
时间窗: at 3 month
National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
Fugl-Meyer (FM) motor scale, short form
时间窗: at 3 month
The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
次要结局
- modified Rankin scale(at 3 month)
研究者
Taewon Kim
Assistant Professor, MD, PhD
Incheon St.Mary's Hospital